July / August 2014

July / August 2014 Cover

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Chemical and Media-Free Pretreatment for Biopharma RO – Electrolysis for Scale Precipitation and UV Dechlorination
by Nissan Cohen and Shlomo Sackstein
This article identifies the issues plaguing water systems with Reverse Osmosis (RO) and defines the proper criteria of operation.

Transfer Station Design for Large Scale API Manufacture (Part Two)
by Joseph R. Hettenbach, PE
This article describes of mother liquor transfer stations, solvent recovery and waste treatment area transfer stations, wall design principles, acceptable alternative standard approaches for process transfer stations, and layout considerations.

Lessons Learned in the Ballroom
by David A. Wolton and Andy Rayner
This article presents an alternative approach to the ballroom concept. It studies the lessons learned from the operation of recently commissioned facilities to predict what the next generation of disposables plant could look like. Will the “Dance Floor” concept be the next step in the evolution of fully disposable facilities?

Pharmaceutical Engineering Interviews Timothy Tyson, Chairman and CEO of Aptuit Inc.
by Gloria Hall
The Chairman and CEO of Aptuit speaks candidly about significant changes in the industry, his evolving leadership and management philosophy, ISPE’s role with influencing change in the industry, and the challenges for industry to increase productivity and reduce risk.

Modeling and Uncertainty Analysis for Pilot Scale Monoclonal Antibody Production
by Noor Zuraihan Mohamad Noor, Ramlan Aziz, Badarulhisam Abdul Rahman, PhD, and Dominic C.Y. Foo, PhD
This article presents the use of computer simulation tools for modeling a pilot scale monoclonal antibody production in a Contract Manufacturing Organization (CMO).

Innovations in UV Oxidation Direct Conductivity TOC Measurement to Improve Accuracy and Precision
by Roger Schmid and Randy Turner
This article presents innovations to improve the accuracy and reliability of UV oxidation direct conductivity TOC measurement methods.

Navigating the Regulatory CMC Landscape in China
by Xiling Song, Min Gui, PhD, and Maurice Parlane
This article discusses the challenges and opportunities that multinational pharmaceutical companies (MNCs) have to influence the dynamically evolving regulatory environment in China.

Induction of Apoptosis by Targeted Ultrasound Contrast Agents in Cancer Therapy
by Lauren J. Jablonowski, Averie M. Palovcak, and Margaret A. Wheatley, PhD
This article presents a proof-of-concept study to determine the ability to target cancer cells through the attachment of a specific ligand to ultrasound contrast agents. It represents the work of a Student Poster Presentation.